Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in K… (NCT07541391) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed/Refractory Disease
Australia12 participantsStarted 2026-05
Plain-language summary
The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed/refractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodepleting conditioning chemotherapy. Considering the poor prognosis of myeloma patients who have relapsed after ≥ 2 lines of therapy, combined with evidence of PMCC-COE-KMA CAR T-cell specificity, as well as the efficacy and manageable toxicity of PMCC-COE-KMA, investigators believe the potential benefits outweigh the risks of this trial.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has provided written informed consent using the KOALA Patient Information and Consent Form (PICF)
✓. Age ≥ 18 years on the day of signing informed consent form
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 (Appendix 2)
✓. Life expectancy of ≥ 3 months, as assessed by the Investigator
✓. A diagnosis of kappa-restricted RR MM with evidence of KMA on the surface of bone marrow plasma cells using flow cytometry analysis as determined by investigator
✓. Have received at least 2 prior lines of therapy including a proteosome inhibitor and an immunomodulatory imide drug with evidence of disease progression as per IMWG criteria (Appendix 1) after the most recent line of therapy Note 1: induction with or without haematopoietic stem cell transplant (SCT), consolidation and maintenance therapy is considered a single line of therapy Note 2: Patients who have had prior treatment with a CAR T-cell therapy are eligible after a minimum of a 12 week washout between infusions.
✓. Have measurable disease as defined by: • Serum IgG, IgA, IgM M protein ≥ 0.5 g/dL; or • Serum IgD M protein ≥ 0.05 g/dL; or • An abnormal free light chain (FLC) assay (Freelite™) demonstrating an excess of kFLC with a kFLC component of at least 100 mg/L and an abnormal k:λ FLC ratio Note: Patients who do not have measurable disease but who have demonstrable disease (i.e., oligo-secretory myeloma) based on evidence of bone lesions by at least 2 prior PET scan studies showing persistent disease may be included
What they're measuring
1
To evaluate the safety of autologous PMCC-COE-KMA in patients with RR MM following lymphodepletion, identifying the maximum tolerated dose (MTD)
Timeframe: From enrollment to the first 28 days after the PMCC-COE-KMA infusion
2
To assess manufacturing feasibility of PMCC-COE-KMA, defined as the percentage of patients in whom a suitable product manufactured, meeting pre-determined criteria for release.
Timeframe: From enrollment to the first 28 days after the PMCC-COE-KMA infusion
✓. Last dose of nitrosourea, nitrogen mustards, or monoclonal antibody must have been at least 4 weeks prior to registration; autologous SCT must have been at least 12 weeks prior to registration; and allogeneic SCT must have been at least 24 weeks prior to registration. Limited field radiotherapy to painful lesions is allowed during Screening and bridging but must be completed 48 hours prior to planned apheresis and lymphodepleting chemotherapy
Exclusion criteria
✕. A diagnosis of lambda-restricted MM
✕. Plasma cell leukaemia at the time of Screening (\> 5% circulating plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
✕. Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
✕. Major surgery within 4 weeks prior to registration
✕. Receipt of a live, attenuated vaccine (except for COVID-19) within 4 weeks prior to the planned commencement of lymphodepleting conditioning
✕. Receipt of any investigational medical product within the last 30 days, or after 5 halflives (whichever is the shortest) prior to planned leukapheresis
✕. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months prior to Screening or class III to IV cardiac disease as defined by the New York Heart Association Functional Classification
✕. Clinically significant neurological disorders (e.g., uncontrolled seizure disorder, severe brain injury, dementia, Parkinson's disease, or autoimmune/inflammatory disorders \[e.g., Guillain-Barre syndrome, motor neuron disease, chronic inflammatory demyelinating polyneuropathy\]) Note: Patients with a seizure disorder who have been seizure free and without modification to anti-epileptic therapy in the past 12 months are eligible